subpart_subject: "Regulatory Review Period Determinations"
section_number: "60.26"
section_subject: "Final action on regulatory review period determinations."
cfr_reference: "21 CFR 60.26"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 1 to 99"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)FDA will consider a regulatory review period determination to be final upon expiration of the 180-day period for filing a due diligence petition under § 60.30 unless FDA receives:
(1)New information from PTO records, FDA records, or FDA centers that affects the regulatory review period determination;
(2)A request under § 60.24 for revision of the regulatory review period determination;
(3)A due diligence petition filed under § 60.30; or
(b)FDA will notify PTO that the regulatory review period determination is final upon:
(1)The expiration of the 180-day period for filing a due diligence petition; or
(2)If FDA has received a request for a revision, a due diligence petition, or a request for a hearing, upon resolution of the request for a revision, the petition, or the hearing, whichever is later. FDA will send a copy of the notification to the applicant and file a copy of the notification in the docket established for the application in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.